Kornimate/medical-research-clean huggingface dataset:
implementation of a pharmacy-intervention to enhance prescription and use of lipid-lowering drugs

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to determine the effectiveness of maximal support of community pharmacies to implement a pharmaceutical care model for improving underprescription and treatment persistence regarding lipid-lowering medication in patients with cardiovascular disease.

cardiovascular disease is the main cause of death in large parts of the world. next to life style changes, pharmaceutical treatment is a keystone in the treatment of cardiovascular disease. despite the strong evidence for the effectiveness of lipid-lowering therapy, less than half of the people eligible are treated. with specific medication searches in the community pharmacy database, an easy tool for detecting patients who are undertreated is available. based on this tool, a pharmaceutical care model for improving underprescription and treatment persistence regarding lipid-lowering medication in patients with cardiovascular disease was constructed. moreover, it is not known yet how to implement this pharmaceutical care model in community pharmacies effectively. with multifaceted interventions the behaviour of health professionals can be changed. in this study the effectiveness of a maximal support strategy, including interactive educational meetings, reminders, audit and feedback, is compared to a minimal implementation strategy.

Eligibility criteria:
inclusion criteria: * pharmacies: resident in the south of the netherlands * patients: with antiplatelet therapy and without lipid-lowering medication exclusion criteria:for patients: * terminal disease * severe mental disorder

Keywords: quality of health care prescriptions, drug anticholesteremic agents community pharmacy services
prospective analysis between amiodarone versus lidocaine in svt

Conditions: Arrhythmias Ventricular

Summary: introduction: recent studies have suggested that other medications may be superior to amiodarone in controlling ventricular arrhythmias. however, a prospective and randomized comparison with lidocaine has not yet been described. objective: this study aims to evaluate the effectiveness and safety of the use of amiodarone versus lidocaine in patients with stable ventricular tachycardias. methodology: for this, a unicentric, randomized and prospective study will be carried out, in which the two drugs will be administered in a comparative manner. hospital data (test results, medical outcomes, arrhythmia reversal, complications) of patients will be analyzed for safety and effectiveness. expected results: the use of lidocaine is not inferior to amiodarone in the tolerability and reversion of stable ventricular tachycardias.


Eligibility criteria:
inclusion criteria: * adult men and women\> 18 years old * presence of sustained ventricular tachycardia with hr\> 120 bpm * systolic blood pressure\> 90 mmhg * no signs of poor peripheral perfusion * absence of dyspnea * absence of severe angina * signed consent form exclusion criteria: * pregnancy * hemodynamic instability * body mass index greater than 40 kg / m2 * use of intravenous amiodarone or lidocaine in the last 24 hours * acute coronary syndrome * presence of tachycardia with irregular or supraventricular rr * contraindications to study drugs

Keywords: lidocaine amiodarone
study of efficacy and safety of brolucizumab versus panretinal photocoagulation laser in patients with proliferative diabetic retinopathy

Conditions: Proliferative Diabetic Retinopathy

Summary: the purpose of this study is to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (prp) in patients with proliferative diabetic retinopathy (pdr). this evaluation will provide information that brolucizumab is non-inferior to prp with respect to the change in best corrected visual acuity at week 54.

the study is an ongoing, phase iii, 96-week, two-arm, randomized (1:1 ratio), single-masked, multi-center, active-controlled study to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation (prp) in subjects with proliferative diabetic retinopathy (pdr). subjects who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of the following treatments: * brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through week 90, with the option from week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks and revert to q12w if disease worsens. more frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the investigator if the disease worsens. * prp: initial treatment in 1-4 sessions up to week 12, followed with additional prp treatment (may split into 2-4 sessions) as needed up to week 90. visits occurred every 6 weeks throughout the study, regardless of treatment or not.

Eligibility criteria:
inclusion criteria: * signed informed consent must be obtained prior to participation * able to complete adequate fundus photographs and retinal images * diagnosis of type 1 or 2 diabetes mellitus (dm) and hba1c less than or equal to 12% at screening * dm treatment stable for at least 3 months * pdr diagnosis with no previous prp treatment in the study eye exclusion criteria: * concomitant conditions or ocular disorders in the study eye at screening or baseline that could compromise a response to study treatment. * presence of diabetic macular edema in the study eye * active infection or inflammation in the study eye * uncontrolled glaucoma (iop greater than 25 mmhg) * intravitreal anti-vegf treatment within 6 months * treatment with intraocular corticosteroids * end stage renal disease requiring dialysis or kidney transplant * uncontrolled blood pressure * systemic anti-vegf therapy at any time other protocol-defined inclusion/exclusion criteria may apply.

Keywords: proliferative diabetic retinophathy, retinal neovascularization, anti-vegf, brolucizumab, intravitreal injection, panretinal photocoagulation
feasibility and acceptability of recognitionvr-based cognitive stimulation in surgical patients

Conditions: Surgery; Delirium; Delirium, Post-Operative

Summary: this study aims to assess the feasibility, acceptability, and safety of using recognitionvr virtual reality-based software in older surgical patients. results from this study will be used to inform the design of a future study in critically ill hospitalized patients at risk for delirium.

virtual reality (vr) imitates reality by creating an artificial 3-dimensional (3d) environment using computing technology or software. a virtual environment (ve) is created using this software with a headset, which cognitively stimulates the user's brain to think they are in an artificial world. creating a ve allows flexibility and measurement of different types of stimuli while recording the various responses provided by users in the controlled ve. vr strengthens the brain's ability to focus, learn, and retain experience. vr for attention deficit disorders has been reported to have promising results. we followed in similar footsteps and designed and developed a novel, 3d simulated software platform prototype called recognition vr to provide vr-based cognitive exercises. a feasibility clinical trial conducted by our group tested the recognitionvr cognitive interventions on older and young healthy volunteers (nct05583903). the results of this study showed that recognitionvr-based cognitive exercises were feasible, acceptable, and tolerable by older healthy subjects. in stage 2 of our research study, we want to evaluate the safety, feasibility, acceptability, and tolerability of vr-based cognitive exercises in 60-year-old or older patients following abdominal surgery admitted to the surgical floor at houston methodist hospital (hmh). our premise is that vr-based cognitive stimulation software will allow the controlled delivery of structured cognitive exercises focusing on orientation, attention, memory, and executive functions. the system will allow customized frequency and duration of cognitive exercises based on the users' difficulty level in a delightfully relaxed environment with beach wave sounds.

Eligibility criteria:
inclusion criteria: * ≥60 years of age * scheduled to undergo the following abdominal surgeries (open or laparoscopic or robotic assisted): small bowel and large bowel surgery; cholecystectomy; whipple procedure; pancreatectomy; splenectomy. * richmond agitation-sedation scale (rass) score 0 exclusion criteria: * subjects with baseline cognitive impairment * person with active psychiatric disorders and being treated with medications, especially schizophrenia * person who is deaf or blind * person with an underlying cognitive disorder or associated phobias (e.g., claustrophobia) * person participating in other clinical trials involving drugs, biologics, devices, or behavioral interventions * active seizure disorders

Keywords: abdominal surgery virtual reality
bioequivalence study of 2.5-mg saxagliptin and 500-mg glucophage in tablets and a fixed-dose combination tablet in healthy participants

Conditions: Type 2 Diabetes Mellitus

Summary: to demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (fdc) tablet to that of 2.5-mg saxagliptin (onglyza) and 500-mg metformin (glucophage, marketed in canada by sanofi-aventis) tablets coadministered to healthy participants in the fasted and fed states.


Eligibility criteria:
inclusion criteria: * men and women, aged 18 to 55 years, inclusive * healthy participants as determined by a lack of clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations * body mass index of 18 to 32 kg/m\^2, inclusive exclusion criteria: * any significant acute or chronic medical illness * current or recent (within 3 months) gastrointestinal disease * any major surgery within 4 weeks of study drug administration * history of allergy to dpp-4 inhibitors or related compounds * history of allergy or intolerance to metformin or other similar acting agents * previous exposure to saxagliptin * exposure to metformin within 3 months pervious to study drug administration * estimated creatinine clearance of \<80 ml/min using the cockcroft gault formula
stand & move at work

Conditions: Obesity; Hypertension; Diabetes

Summary: a trial testing the efficacy of sit-stand workstations on decreasing sitting time and increasing light-intensity physical activity in samples of office worksites.

with traditional approaches to increasing mvpa (moderate to vigorous physical activity) in the workplace being unsustainable due to the requirement of deliberate and dedicated time away from work, this group-randomized trial will test the efficacy of sit-stand workstations on decreasing sitting time and increasing light-intensity physical activity (lpa) in a highly generalizable sample of office worksites using a multi-level intervention with high potential for dissemination.

Eligibility criteria:
inclusion criteria: worksite-level inclusion criteria: * size: small to moderate size worksite (20-60 employees) * schedule: \>80% of employees full time * occupation: seated office work, primarily computer- and- telephone-based work, little movement or walking * wellness environment: not currently undergoing a wellness program aimed at increasing activity at work * workstations: willing to have sit-stand workstations installed at a worksite * willing to be randomized: willing to be randomized to either intervention conditions member-level inclusion criteria: * age: 18 years and older * health status: generally good health and able to safely increase lpa and reduce sitting time * employment status: any sedentary job, sitting most of the say, little standing or walking * occupation: traditional sitting desk, willing to have a sit-stand workstation installed at desk * workstation: traditional sitting desk;willing to have a sit-stand workstation installed at desk exclusion criteria: * contraindication to prolonged standing at work
suboxone: (buprenorphine/naloxone) comparison of two taper schedules - 1

Conditions: Opioid-Related Disorders

Summary: the purpose of this protocol is to to compare the clinical utility of two dosage tapering regimens in buprenorphine/naloxone stabilized subjects for opiate detoxification.


Eligibility criteria:
inclusion criteria: * females are not pregnant or lactating * subjects meet dsm-iv criteria for opiate dependence, are medically and psychiatrically stable, and do not have a current history of benzodiazepine dependence abuse, dependence, or treatment

Keywords: opiate dependence
a study to evaluate the effects of anti-hiv drugs in hiv-positive patients who also have hepatitis c infection

Conditions: HIV Infections; Hepatitis C

Summary: this study evaluates patients infected with both hiv and hepatitis c virus (hcv) who are receiving anti-hiv drugs. the purpose of this study is to learn more about hcv infection in patients whose hiv blood level decreases to less than 500 copies/ml.

sixty naive patients with hiv and confirmed hepatitis c who are co-enrolled in another aactg antiretroviral study that involves the testing of haart (highly active antiretroviral therapy) are entered on this prospective study. patients who are defined as naive have never received specific, active antiretroviral agents that sustain viral suppression below the limit of detection (500 copies/ml) or have received those agents for only a very limited time. haart is defined as therapy which is likely to result in hiv-1 rna plasma levels less than 500 copies/ml for at least 16 weeks. plasma is collected and evaluated during the study for additional quantitative measurements: hepatitis c virus (hcv) by hcv rna pcr and hiv-1 rna levels. all evaluations for hiv-1 rna are obtained from the co-enrolled study at the following time points: pre-entry, entry, at least 2 measurements before week 16, week 16, and at least 1 measurement after week 16.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are hiv-positive and have hepatitis c. * have an hiv blood level of at least 2,500 copies/ml 30 days before study entry. * are co-enrolled in an active adult aids clinical trial using anti-hiv treatment. * are at least 13 years of age (parent or guardian consent required if under 18). exclusion criteria patients will not be eligible for this study if they: * have liver disease. * have cancer requiring chemotherapy. * have hepatitis b. * abuse alcohol and/or drugs. * have received certain antiretroviral (anti-hiv) drugs in the past.

Keywords: hiv-1 drug therapy, combination hepatitis c rna, viral anti-hiv agents
effect of resistive exercise on insomnia in post menopausal women

Conditions: Sleep Disturbances and Insomnia

Summary: the aim of this study is to investigate the efficacy of resistive exercise on insomnia in post menopausal women

insomnia is a prevalent condition in post menopausal women.resistive exercise might play an important role in insomnia.this trial has two groups ;one will receive advices and the second will receive advices and resistive exercise for four week

Eligibility criteria:
inclusion criteria: 1. age from 50 to 65 years 2. non smokers 3. bmi 25:29.9 4. post menopausal women suffer from insomnia exclusion criteria: 1. post menopausal women suffer from any medical problems lead to sleep disturbance and insomnia 2. women on hormone replacement therapy 3. those with diagnosed osteoporosis

Keywords: resistive exercise, insomnia, post menopausal women
register for pediatric patients with antiphospholipid syndrome (aps): european project extended internationally study

Conditions: Antiphospholipid Syndrome

Summary: the purpose of this study is to gather information about causes and treatment of antiphospholipid syndrome.


Eligibility criteria:
inclusion criteria: * 18 years of age or younger at the onset of disease * presence of vascular thrombosis * uc davis patient * presence of at least one laboratory criteria including: anticardiolipin antibody, anti-b glycoprotein-i antibody or lupus anticoagulant in plasma exclusion criteria: * infants born to mothers with aps * infants with congenital thrombophilia

Keywords: antiphospholipid syndrome
telemedicine to improve use of therapeutic hypothermia in rural settings

Conditions: Neonatal Encephalopathy

Summary: this pilot intervention trial will assess the feasibility of a live consultation between community hospital providers and tertiary care providers employing a novel teleconsult platform, maine neonatal encephalopathy teleconsult (maine net), on the time to initiation of therapeutic hypothermia (th) for 35 infants born in community hospitals in maine compared with matched historical controls. community hospital providers and tertiary care center provider satisfaction with the maine net platform will also be assessed. the hypothesis is that immediately available expert assessment via a teleconsult platform will promote earlier implementation of th and be associated with high levels of provider satisfaction.

the study will recruit a total of 125 infants from the participating centers and anticipate that 35 of these subjects will be treated with therapeutic hypothermia and be utilized for the comparative analysis to historical controls. not all infants recruited and provided a maine net consultation will be treated with th and to have an adequate sample size to make statistical comparisons with historical controls we need to enroll more than 35 participants to ensure 35 have been treated with th for the comparative analysis. in a secondary qualitative study, clinicians who completed maine net consults through the above clinical trial were interviewed about their experience with the consult. this secondary study will recruit up to 20 clinicians who completed a consult in this clinical trial.

Eligibility criteria:
inclusion criteria: infants included in this study will be born at a community hospital, will be in either high or moderate risk, will be younger than 6 hours of age at the time of the consultation and the decision will have been made to treat with th. high risk infants will be defined as an umbilical cord ph of less than or equal to 7.0 or 5 minute apgar score of less than or equal to 5 or a need for resuscitation (including respiratory support or chest compressions) or an abnormal exam (which may include flaccid tone, poor suck reflex or poor response to stimulation) or seizures at less than 6 hours of life. moderate risk infants will be defined as an umbilical cord ph of less than or equal to 7.2 but greater than 7.0 or 5 minute apgar score of less than 7 but greater than 5 or a perinatal event (such as placental abruption, uterine rupture, cord prolapse, or fetal-maternal hemorrhage) or an abnormal exam (which may include a hyper-alert state). exclusion criteria: infants older than 6 hours at the time maine net is requested and infants for whom th is not an appropriate therapy (e.g. due to premature birth or moribund status) will be excluded.

Keywords: hypothermia, induced telemedicine hospitals, community
impact evaluation of wfp's fresh food voucher pilot programme in ethiopia

Conditions: Diet; Deficiency; Malnutrition

Summary: to assess the impact of wfp's fresh food voucher pilot programme in ethiopia on children's and mother's diets

rationale: infants, young children and adult women in rural ethiopia consume one of the least diversified diets in the world. the world food programme's fresh food voucher (ffv) pilot programme aims to improve dietary diversity among infants and young children and their mothers. the focus on these demographic groups is based on the now well-established theory on the importance of the 'first 1,000 days'. this period, spanning the pregnancy and the first 2 years of child's life, is considered critical for child's physical growth and cognitive development. the beneficiary households receive a voucher that can be used to purchase fresh foods (fruits, vegetables and certain animal source foods). objective: the main objectives of the evaluation are to assess and report on the performance and results of the ffv programme to help wfp present high-quality and credible evidence of actual impact to its donors. in addition, the evaluation will determine the reasons why certain results occurred (or not) to draw lessons, derive good practices and pointers for learning. study design: this is a mixed methods evaluation that combines a randomized controlled trial (rct) with focus group discussions (fgds) with caregivers and food traders. the rct contains three arms. the first treatment arm receives a smaller voucher (roughly $12-17) and social behavioural change communication (sbcc). the second treatment arm receives a larger voucher (roughly $21-23) and sbcc. households in the third study arm (control) receive sbcc but do not receive vouchers. a cluster in this impact evaluation is defined as a village (got in amharic) and these clusters of are randomly allocated to the different arms of the trial. within a cluster, all eligible households will receive the same treatment. study population: all households with a child between 6-17 months at the baseline in december 2017 were eligible to be included in the quantitative sample. main study parameters/endpoints: the main outcomes of interest are minimum acceptable diet score for children 6- 23 months (world health organization, 2008) and minimum diet diversity for women of reproductive age (fao \& fhi-360, 2016).

Eligibility criteria:
inclusion criteria: households with young children aged 6-17 months age at the baseline in december 2017.

Keywords: dietary diversity minimum acceptable diet fruits vegetables animal sourced foods
a dose-escalating clinical trial with kh176

Conditions: MELAS; LHON; Leigh Syndrome; Mitochondrial Disease; Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation

Summary: mitochondrial diseases are rare progressive, multi-system, often early fatal disorders affecting both children and adults. kh176 is a novel chemical entity currently under development for the treatment of inherited mitochondrial diseases, including melas (mitochondrial encephalomyopathy, lactic acidosis, and stroke-like episodes), leigh's disease and leber's hereditary optic neuropathy (lhon). kh176 is a potent intracellular redox modulating agent targeting the reactive oxygen species which are important in the pathogenesis of disorders of mitochondrial oxidative phosphorylation. after demonstrating a favourable safety profile in the pre-clinical testing, the safety, tolerability and pharmacokinetic and pharmacodynamic characteristics of the compound will now be evaluated in healthy male subjects in this trial


Eligibility criteria:
inclusion criteria: * healthy as assessed by medical history, physical examination, vital signs, clinical laboratory, ecg exclusion criteria: * allergies, * concomitant medication, * concomitant disease, * relevant surgery, * recent blood donation